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ARTICLE | Clinical News

Debiopharm completes enrollment in Phase I/II of Debio 1143 for SCCHN

July 21, 2017 8:34 PM UTC

Debiopharm Group (Lausanne, Switzerland) completed enrollment of 96 patients with previously untreated, locally advanced squamous cell carcinoma of the head and neck (SCCHN) in the Phase II portion of a double-blind, placebo-controlled, French and Swiss Phase I/II trial of oral Debio 1143 (AT-406) in combination with chemo-radiation therapy (CRT). Debio 1143 is a small molecule inhibitor of apoptosis (IAP).

The trial is evaluating Debio 1143 daily for 14 days every three weeks in combination with cisplatin and radiotherapy in patients with previously untreated stage III, IVa or IVb SCCHN. The Phase I primary endpoint is maximum tolerated dose (MTD). The primary endpoint of the Phase II portion is the percentage of patients achieving locoregional control at 18 months from the end of CRT. Secondary endpoints include locoregional control rates at prespecified time points, complete response rate, overall response rate (ORR), disease control rate (DCR), progression-free survival (PFS), overall survival (OS) and safety...

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Inhibitor of apoptosis (IAP)